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Changes in Out-of-Pocket Drug Expenditures Among Medicare Beneficiaries With Dementia Under the Inflation Reduction Act: A Simulation Study.
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-27 DOI: 10.1016/j.jval.2025.01.008
Yingying Zhu, Natalia Olchanski, Karen M Freund, Joshua T Cohen, Peter J Neumann, Pei-Jung Lin

Objectives: We investigated how the Inflation Reduction Act (IRA) Medicare Part D benefit redesign may reduce out-of-pocket (OOP) drug expenditures for Medicare beneficiaries with dementia.

Methods: Using data from the Health and Retirement Study (HRS) linked with Medicare claims, we simulated post-redesign OOP drug spending by applying the 2025 prescription drug cost-sharing rules to each beneficiary's pre-redesign Part D medication utilization for 2016, adjusting for inflation. Our study population comprised HRS respondents aged 65 and older in 2016, enrolled in Medicare fee for service, with at least one Part D drug claim in 2016, and diagnosed with dementia between 2000 and 2016 (n = 1677). We compared pre-redesign and post-redesign annual OOP drug expenditures stratified by: (1) low-income subsidy (LIS) eligibility status; (2) household income among non-LIS beneficiaries; (3) comorbidity count, and 4) cognitive impairment severity.

Results: After the redesign, we project average annual OOP drug expenditures among LIS beneficiaries with dementia to decrease from $56 to $25-representing a $31, or 55%, reduction. In contrast, among non-LIS beneficiaries, average OOP drug expenditures is projected to decrease from $772 to $576, a $196, or 25% reduction. We project the reduction in OOP drug expenditures to be greater among beneficiaries with 6 to 8 comorbidities (45%) than among beneficiaries with fewer comorbidities (21%-26%).

Conclusions: The Inflation Reduction Act Medicare Part D benefit redesign will reduce OOP drug spending for beneficiaries with dementia, resulting in potentially marked savings not only for low-income beneficiaries and beneficiaries with a high comorbidity burden but also for higher-income beneficiaries.

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引用次数: 0
Rare Disease Policy in High-Income Countries: An Overview of Achievements, Challenges, and Solutions.
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-27 DOI: 10.1016/j.jval.2024.12.009
Arianna Gentilini, Emilie Neez, Durhane Wong-Rieger

Objectives: To provide an overview of policy initiatives in high-income countries aimed at supporting the development and accessibility of treatments for rare diseases.

Methods: We examine how legislative, research, and pricing policies in high-income countries address barriers that have historically hindered innovation and access to rare disease treatments. By analyzing examples from the European Union, United Kingdom, United States, Canada, Japan, and Australia, the article identifies ongoing initiatives, outlines current challenges, and explores proposed solutions to foster a sustainable, innovative, and accessible rare disease treatment ecosystem.

Results: The review highlights policies such as legislative incentives in the European Union, United States, and Japan for orphan drug development, public-private partnerships to boost innovation, and patient registries to support research and clinical trials. Despite these efforts, major challenges persist, including high therapy costs, limited access to innovation for ultrarare diseases, and diagnostic delays, with significant disparities across regions.

Conclusions: Overcoming these challenges will require sustainable pricing and reimbursement frameworks, alongside stronger collaboration between stakeholders, particularly for ultrarare diseases. Advanced technologies, such as artificial intelligence, hold promise for improving diagnostic accuracy and data collection, supported by enhanced coding systems and registries to facilitate more robust research.

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引用次数: 0
A Comparison of International Modeling Methods for Evaluating Health Economics of Colorectal Cancer Screening: A Systematic Review.
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-27 DOI: 10.1016/j.jval.2025.01.007
Olivia Adair, Felicity Lamrock, James F O'Mahony, Mark Lawler, Ethna McFerran

Objectives: Cost-effectiveness analysis (CEA) is an accepted approach to evaluate cancer screening programs. CEA estimates partially depend on modeling methods and assumptions used. Understanding common practice when modeling cancer relies on complete, accessible descriptions of prior work. This review's objective is to comprehensively examine published CEA modeling methods used to evaluate colorectal cancer (CRC) screening from an aspiring modeler's perspective. It compares existing models, highlighting the importance of precise modeling method descriptions and essential factors when modeling CRC progression.

Methods: MEDLINE, EMBASE, Web of Science, and Scopus electronic databases were used. The Consolidated Health Economic Evaluation Reporting Standards statement and data items from previous systematic reviews formed a template to extract relevant data. Specific focus included model type, natural history, appropriate data sources, and survival analysis.

Results: Seventy-eight studies, with 52 unique models were found. Twelve previously published models were reported in 39 studies, with 39 newly developed models. CRC progression from the onset was commonly modeled, with only 6 models not including it as a model component.

Conclusions: Modeling methods needed to simulate CRC progression depend on the natural history structure and research requirements. For aspiring modelers, accompanying models with clear overviews and extensive modeling assumption descriptions are beneficial. Open-source modeling would also allow model replicability and result in appropriate decisions suggested for CRC screening programs.

目的:成本效益分析(CEA)是评估癌症筛查计划的一种公认方法。成本效益分析的估计值部分取决于所使用的建模方法和假设。要了解癌症建模的常见做法,需要对先前的工作进行完整、易懂的描述。本综述旨在从一个有抱负的建模者的角度,全面考察已发表的用于评估结直肠癌(CRC)筛查的 CEA 建模方法。它对现有模型进行了比较,强调了精确建模方法描述的重要性,以及建立 CRC 进展模型时的基本要素:方法:使用 MEDLINE、EMBASE、Web of Science 和 Scopus 电子数据库。综合卫生经济评估报告标准(CHEERS)声明和以往系统综述中的数据项构成了提取相关数据的模板。具体重点包括模型类型、自然历史、适当的数据来源和生存分析:结果:共发现 78 项研究,52 个独特的模型。39 项研究报告了 12 个以前发表的模型,39 个新开发的模型。从发病开始的 CRC 进展模型很常见,只有 6 个模型没有将其作为模型的组成部分:结论:模拟 CRC 进展所需的建模方法取决于自然史结构和研究要求。对于有抱负的建模者来说,随模型提供清晰的概述和广泛的建模假设说明是有益的。开放源码建模还能使模型具有可复制性,并为 CRC 筛查计划提供适当的决策建议。
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引用次数: 0
Developing an Australian Value Set for the Recovering Quality of Life-Utility Index Instrument Using Discrete Choice Experiment With Duration 使用持续时间的离散选择实验为恢复生活质量-效用指数(ReQoL-UI)工具开发澳大利亚值集。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-17 DOI: 10.1016/j.jval.2024.12.008
Thao Thai PhD , Lidia Engel PhD , Jemimah Ride PhD , Brendan Mulhern PhD , Richard Norman PhD , Cathrine Mihalopoulos PhD

Objectives

The Recovering Quality of Life-Utility Index (ReQoL-UI) instrument was designed to measure the quality-of-life outcomes for people older than 16 years with mental health problems. We aimed to elicit societal preferences for the ReQoL-UI health states to facilitate better decision making in Australia.

Methods

A discrete choice experiment with duration was embedded in a self-completed online survey and administered to a representative sample (n = 1019) of the Australian adult population aged 18 years and older stratified by age, sex, and geographic location. A partial subset design discrete choice experiment was used with 3 fixed attributes and 5 varying attributes, containing 240 choice tasks that were divided into 20 blocks so that each respondent was assigned a block of 12 choice tasks. The value set was modeled using the conditional logit model with utility decrements directly anchored on the 0 to 1 dead-full health scale. Preference heterogeneity was tested using a mixed logit model.

Results

The final value set reflects the monotonic nature of the ReQoL-UI descriptive systems where the best health state defined by the descriptive system has a value of 1 and the worst state has a value of −0.585. The most important dimension was physical health problems, whereas the least important attribute was self-perception. Sensitivity and preference heterogeneity analyses revealed the stability of the value set.

Conclusions

The value set, which reflects the preferences of the Australian population, facilitates the calculation of an index for quality-adjusted life-years in mental health intervention cost-utility analyses.
目的:设计康复生活质量-效用指数(ReQoL-UI)测量16岁以上有心理健康问题人群的生活质量结果。我们的目标是引出社会对ReQoL-UI健康状态的偏好,以促进澳大利亚更好的决策。方法:将离散选择实验(DCE)嵌入一份自我完成的在线调查中,并对具有代表性的样本(n=1019)进行管理,这些样本年龄在18岁及以上,按年龄、性别和地理位置分层。采用部分子集设计DCE,其中包含3个固定属性和5个变化属性,包含240个选择任务,这些选择任务被划分为20个块,因此每个被调查者被分配到12个选择任务的块。该值集是使用条件logit模型建模的,其效用递减直接锚定在0到1的完全死亡生命值范围内。采用混合logit模型检验偏好异质性。结果:最终值集反映了ReQoL-UI描述系统的单调性,其中描述系统定义的最佳健康状态值为1,最差状态值为-0.585。最重要的维度是身体健康问题,而最不重要的属性是自我认知。敏感性分析和偏好异质性分析显示了该值集的稳定性。结论:该数值集反映了澳大利亚人口的偏好,便于在心理健康干预成本-效用分析中计算质量调整生命年指数。
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引用次数: 0
Advancing Mental Health Economics: Insights From the Themed Section 推进心理健康经济学:来自主题部分的见解。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-17 DOI: 10.1016/j.jval.2024.12.007
Rachael L. Fleurence PhD, MSc , Jagpreet Chhatwal PhD
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引用次数: 0
Unpaid Caring and Health-Related Quality of Life: Longitudinal Analysis of Understanding Society (the UK Household Longitudinal Survey) 无偿照料和与取暖相关的生活质量:对 "理解社会"(英国家庭纵向调查)的纵向分析。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-01 DOI: 10.1016/j.jval.2024.08.004
Becky M. Pennington MSc, Mónica Hernández Alava PhD, Mark Strong PhD

Objectives

Decision models for economic evaluation are increasingly including health-related quality of life (HRQoL) for informal/unpaid carers, but these estimates often come from poor quality data and typically rely on cross-sectional analysis. We aimed to identify within-person effects using longitudinal analysis of 13 waves of Understanding Society (the UK Household Longitudinal Survey).

Methods

We analyzed data for coresident carer and care-recipient dyads, where the carer reported “looking after or giving special help to” the care recipient in any of the 13 waves. We used fixed-effects models to study the effects of caring for the care recipient (the “caregiving” effect) using volume of care (hours per week) and continuous duration of caregiving (years) and caring about the care recipient (the “family” effect) using the care recipient’s HRQoL on the carer’s HRQoL. HRQoL was measured using the Short Form 6 Dimension, calculated from the Short Form 12.

Results

We found consistent evidence for the family effect: improving care recipient’s HRQoL by 0.1 would improve carer’s HRQoL by approximately 0.012. We also consistently found evidence of a small but statistically significant decrement to carer’s HRQoL for each additional year of caring. These findings were robust to scenario analyses. Evidence for the relationship between volume of care and carer’s HRQoL was less clear.

Conclusions

We propose that our estimates can be used to populate economic models to predict changes in carers’ HRQoL over time and allow disutilities to be estimated separately for the family and caregiving effect.
目的:用于经济评估的决策模型越来越多地包括非正式/无偿照护者的健康相关生活质量(HRQoL),但这些估算通常来自质量较差的数据,而且通常依赖于横截面分析。我们的目标是通过对 13 次 "了解社会"(英国家庭纵向调查)的纵向分析来确定人内效应:我们分析了同住照护者和受照护者二元组的数据,其中照护者在 13 次调查中的任何一次中都报告了 "照护或给予特别帮助 "受照护者的情况。我们使用固定效应模型来研究照顾受照顾者("照顾 "效应)对照顾者的影响(使用照顾量(每周小时)和连续照顾时间(年));以及照顾受照顾者("家庭 "效应)对照顾者的影响(使用受照顾者的 HRQoL)。HRQoL 采用简表 6 维(SF-6D)进行测量,由 SF-12 计算得出:我们发现了家庭效应的一致证据:护理对象的 HRQoL 提高 0.1 将使护理者的 HRQoL 提高约 0.012。我们还一致发现,照顾者每多照顾一年,其 HRQoL 就会略有下降,但在统计学上具有显著意义。这些发现在情景分析中都是可靠的。护理量与照护者 HRQoL 之间关系的证据不太明确:我们建议将我们的估算结果用于经济模型,以预测照护者的 HRQoL 随时间的变化,并分别估算家庭效应和照护效应的损失。
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引用次数: 0
Most Common Symptomatic Adverse Reactions of Cancer Treatments From US Drug Labels (2015-2021) to Inform Selection of Patient-Reported Outcomes 美国药品标签中癌症治疗最常见的症状性不良反应(2015-2021 年),为选择患者报告结果提供依据。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-01 DOI: 10.1016/j.jval.2024.09.009
Erica G. Horodniceanu MPH , Tejaswi Datla , Meena N. Murugappan PharmD, MPH, PhD , Bindu Kanapuru MD , Laleh Amiri-Kordestani MD , Erin Larkins MD , Paul Kluetz MD , Vishal Bhatnagar MD

Objectives

Incorporating patient-reported outcomes (PROs) to assess symptomatic adverse events (AEs) in cancer clinical trials (CTs) is important to characterize treatment tolerability. Cancer therapies approved over the past decade have expanded the types of expected toxicities. To inform future symptomatic AE PRO item selection, we identified the most common symptomatic adverse reactions from recently approved products.

Methods

We reviewed approvals from 2015 to 2021 for lung, breast, and hematologic cancer indications. Using United States Prescribing Information safety data, we recorded symptomatic adverse reactions reported in ≥20% of patients in the experimental arm of CTs supporting approvals. We calculated the proportion of arms reporting each symptomatic adverse reaction.

Results

In total, 130 experimental arms were included (lung = 30, breast = 10, hematologic = 90). For all cancer types, fatigue and diarrhea were reported in >50% of the arms. Nausea was reported in ≥50% of the arms for all except lung. Vomiting, decreased appetite, and alopecia, were reported in ≥50% of breast cancer arms. Rash, musculoskeletal pain, and cough were reported in >50% of leukemia/lymphoma arms. Cough was common (50%) in multiple myeloma arms.

Conclusions

Heterogeneity in symptomatic adverse reactions across CTs supports the use of item libraries when building a PRO strategy to assess tolerability. Fatigue, diarrhea, and nausea were the most frequent symptomatic adverse reactions reported in contemporary cancer CTs and could provide a starting point when selecting PRO symptomatic AE items. Additional symptomatic AE PRO items should be selected based on the mechanism of action, early clinical data, published literature, and patient and clinician input.
目的:在癌症临床试验(CTs)中纳入患者报告结果(PROs)来评估症状性不良事件(AEs)对于描述治疗耐受性非常重要。过去十年中批准的癌症疗法扩大了预期毒性的类型。为了给未来的症状性 AE PRO 项目选择提供信息,我们确定了最近批准的产品中最常见的症状性不良反应:我们回顾了 2015-2021 年肺癌、乳腺癌和血液肿瘤适应症的批准情况。利用美国处方信息安全性数据,我们记录了支持批准的 CT 实验臂中≥20% 的患者报告的症状性不良反应。我们计算了报告每种症状性不良反应的试验组比例:结果:共纳入 130 个实验臂(肺癌=30 个,乳腺癌=10 个,血液肿瘤=90 个)。在所有癌症类型中,超过 50% 的实验组报告了疲劳和腹泻。除肺癌外,≥50% 的实验组报告有恶心症状。≥50%的乳腺癌治疗组出现呕吐、食欲下降和脱发。在白血病/淋巴瘤治疗组中,报告皮疹、肌肉骨骼疼痛和咳嗽的比例>50%。在多发性骨髓瘤治疗组中,咳嗽很常见(50%):结论:不同临床试验中症状性不良反应的异质性支持在建立PRO策略以评估耐受性时使用项目库。疲劳、腹泻和恶心是当代癌症 CT 中最常见的症状性不良反应,可作为选择 PRO 症状性 AE 项目的起点。应根据作用机制、早期临床数据、已发表文献以及患者和临床医生的意见选择其他症状性 AE PRO 项目。
{"title":"Most Common Symptomatic Adverse Reactions of Cancer Treatments From US Drug Labels (2015-2021) to Inform Selection of Patient-Reported Outcomes","authors":"Erica G. Horodniceanu MPH ,&nbsp;Tejaswi Datla ,&nbsp;Meena N. Murugappan PharmD, MPH, PhD ,&nbsp;Bindu Kanapuru MD ,&nbsp;Laleh Amiri-Kordestani MD ,&nbsp;Erin Larkins MD ,&nbsp;Paul Kluetz MD ,&nbsp;Vishal Bhatnagar MD","doi":"10.1016/j.jval.2024.09.009","DOIUrl":"10.1016/j.jval.2024.09.009","url":null,"abstract":"<div><h3>Objectives</h3><div>Incorporating patient-reported outcomes (PROs) to assess symptomatic adverse events (AEs) in cancer clinical trials (CTs) is important to characterize treatment tolerability. Cancer therapies approved over the past decade have expanded the types of expected toxicities. To inform future symptomatic AE PRO item selection, we identified the most common symptomatic adverse reactions from recently approved products.</div></div><div><h3>Methods</h3><div>We reviewed approvals from 2015 to 2021 for lung, breast, and hematologic cancer indications. Using United States Prescribing Information safety data, we recorded symptomatic adverse reactions reported in ≥20% of patients in the experimental arm of CTs supporting approvals. We calculated the proportion of arms reporting each symptomatic adverse reaction.</div></div><div><h3>Results</h3><div>In total, 130 experimental arms were included (lung = 30, breast = 10, hematologic = 90). For all cancer types, fatigue and diarrhea were reported in &gt;50% of the arms. Nausea was reported in ≥50% of the arms for all except lung. Vomiting, decreased appetite, and alopecia, were reported in ≥50% of breast cancer arms. Rash, musculoskeletal pain, and cough were reported in &gt;50% of leukemia/lymphoma arms. Cough was common (50%) in multiple myeloma arms.</div></div><div><h3>Conclusions</h3><div>Heterogeneity in symptomatic adverse reactions across CTs supports the use of item libraries when building a PRO strategy to assess tolerability. Fatigue, diarrhea, and nausea were the most frequent symptomatic adverse reactions reported in contemporary cancer CTs and could provide a starting point when selecting PRO symptomatic AE items. Additional symptomatic AE PRO items should be selected based on the mechanism of action, early clinical data, published literature, and patient and clinician input.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"28 1","pages":"Pages 108-115"},"PeriodicalIF":4.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Primer on Health Equity Research in Health Economics and Outcomes Research: An ISPOR Special Interest Group Report 卫生经济学和成果研究中的卫生公平研究入门:ISPOR特别兴趣小组报告。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-01 DOI: 10.1016/j.jval.2024.09.012
Matthew J.S. Griffiths MSc , Richard Cookson PhD , Anton L.V. Avanceña PhD , Manuel A. Espinoza PhD , Caroline M. Jacobsen MPhil , Jesse Sussell PhD , Stacey Kowal MSc

Objectives

Disparities in health and healthcare between more and less socially advantaged groups are pervasive, multidimensional, and far-reaching. The material and social conditions in which people are born, grow, work, live, and age are systematically associated with their health and with the volume, quality, and outcomes of care received by the vast majority of the general population, as well as by specific marginalized populations. The field of health economics and outcomes research (HEOR) has an important role in supporting health equity goals. This publication aimed to act as a “primer” for conducting health equity research within the field of HEOR, establishing foundational understanding of key concepts.

Methods

The ISPOR Special Interest Group on Health Equity Research was established in 2021 to advance equity-informative methods and data to better enable researchers to empirically investigate—and ultimately reduce—unfair social differences in health. This publication was developed by the ISPOR Special Interest Group leadership team with input from the group membership.

Results

The resultant publication provides an overview of health equity research methods and data considerations as they relate to HEOR-relevant topics including clinical trials, real-world evidence and economic evaluation. Reflecting the current body of research on health equity in HEOR, particular focus is given to the latter. It also brings together a list of core reference material to support future learning.

Conclusions

This report provides the HEOR community with a tailored “state of play” overview of health equity, to support development of foundational understanding and inspire increased engagement.
目标:社会地位较高和较低的群体之间在健康和保健方面的差距是普遍的、多方面的和深远的。人们在其中出生、成长、工作、生活和衰老的物质和社会条件与他们的健康以及绝大多数普通人口以及特定边缘人口所获得的护理的数量、质量和结果有系统的联系。卫生经济学和成果研究(HEOR)领域在支持卫生公平目标方面具有重要作用。该出版物旨在作为在高等教育资源领域开展卫生公平研究的“入门书”,建立对关键概念的基本理解。方法:ISPOR健康公平研究特别兴趣小组成立于2021年,旨在推进公平信息方法和数据,使研究人员能够更好地进行实证调查,并最终减少健康方面不公平的社会差异。本出版物由ISPOR特别兴趣小组领导小组根据小组成员的意见编写。结果:由此产生的出版物概述了卫生公平研究方法和数据考虑,因为它们与heor相关主题有关,包括临床试验、真实证据和经济评估。考虑到目前关于高等教育资源中卫生公平的研究,本文特别关注后者。它还汇集了一系列核心参考材料,以支持未来的学习。结论:本报告为高等教育机构提供了量身定制的卫生公平“现状”概述,以支持发展基本理解并激发更多参与。
{"title":"Primer on Health Equity Research in Health Economics and Outcomes Research: An ISPOR Special Interest Group Report","authors":"Matthew J.S. Griffiths MSc ,&nbsp;Richard Cookson PhD ,&nbsp;Anton L.V. Avanceña PhD ,&nbsp;Manuel A. Espinoza PhD ,&nbsp;Caroline M. Jacobsen MPhil ,&nbsp;Jesse Sussell PhD ,&nbsp;Stacey Kowal MSc","doi":"10.1016/j.jval.2024.09.012","DOIUrl":"10.1016/j.jval.2024.09.012","url":null,"abstract":"<div><h3>Objectives</h3><div>Disparities in health and healthcare between more and less socially advantaged groups are pervasive, multidimensional, and far-reaching. The material and social conditions in which people are born, grow, work, live, and age are systematically associated with their health and with the volume, quality, and outcomes of care received by the vast majority of the general population, as well as by specific marginalized populations. The field of health economics and outcomes research (HEOR) has an important role in supporting health equity goals. This publication aimed to act as a “primer” for conducting health equity research within the field of HEOR, establishing foundational understanding of key concepts.</div></div><div><h3>Methods</h3><div>The ISPOR Special Interest Group on Health Equity Research was established in 2021 to advance equity-informative methods and data to better enable researchers to empirically investigate—and ultimately reduce—unfair social differences in health. This publication was developed by the ISPOR Special Interest Group leadership team with input from the group membership.</div></div><div><h3>Results</h3><div>The resultant publication provides an overview of health equity research methods and data considerations as they relate to HEOR-relevant topics including clinical trials, real-world evidence and economic evaluation. Reflecting the current body of research on health equity in HEOR, particular focus is given to the latter. It also brings together a list of core reference material to support future learning.</div></div><div><h3>Conclusions</h3><div>This report provides the HEOR community with a tailored “state of play” overview of health equity, to support development of foundational understanding and inspire increased engagement.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"28 1","pages":"Pages 16-24"},"PeriodicalIF":4.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proposal for a General Outcome-Based Value Attribution Framework for Combination Therapies 关于基于成果的组合疗法价值归属总体框架的建议。
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-01 DOI: 10.1016/j.jval.2024.07.019
Lotte Steuten PhD , Mickael Lothgren PhD , Andrew Bruce BSc , Marco Campioni PhD , Adrian Towse MPhil

Objectives

Valuing and pricing the components of combination therapies can be difficult because of competition law issues, difficulty implementing different prices for the same product in alternative uses, and attributing value to each component of the combination. We propose a value attribution solution that allows all combination components to be priced according to their relative value in the combination.

Methods

We developed a value attribution solution that is universal, symmetrical, and neutral to each combination constituent, regardless of whether it is the backbone or the add-on, and complete, meaning that it will always attribute the full value of the combination between the component parts. Moreover, it can be applied to any number of components in the combination (eg, triplets or quadruplets). We compared this solution with 2 other existing approaches.

Results

The results of the proposed value attribution solution sit between those of the 2 other value attribution approaches as it combines elements of each. As the degree of additivity moves further away from one in either direction, then our general approach ratios also move, reflecting the impact of the incremental value.

Conclusions

The proposed value attribution solution for combination therapies differs from 2 existing approaches by being universally applicable and allowing for symmetry when neutral to the constituent components of the combination. To optimally contribute to policy debate and practice, various requirements for its implementation need to be well understood, including how to overcome (1) partial information, (2) whether its assumptions can be relaxed, and (3) implementation issues.
目的:由于竞争法问题、同一产品在不同用途中执行不同价格的困难,以及对组合疗法各组成部分的价值归属问题,对组合疗法各组成部分进行估值和定价可能很困难。我们提出了一种价值归属解决方案,可以根据组合疗法中所有组合成分的相对价值对其进行定价:方法:我们开发了一种价值归属解决方案,它具有通用性、对称性,并且对每个组合成分都是中性的,无论其是主干还是附加成分;它还具有完整性,这意味着它总是在各组成部分之间归属组合的全部价值。此外,它还适用于组合中任何数量的成分(如三胞胎或四胞胎)。我们将这一解决方案与其他两种现有方法进行了比较:结果:建议的价值归属解决方案的结果介于其他两种价值归属方法之间,因为它结合了每种方法的元素。随着可加性程度在任一方向上进一步偏离 1,我们的一般方法比率也会发生变化,从而反映出增量价值的影响:针对组合疗法提出的价值归因解决方案不同于现有的两种方法,它具有普遍适用性,并允许在对组合疗法的组成成分保持中立时实现对称。为了对政策辩论和实践做出最佳贡献,需要充分了解其实施的各种要求,包括如何克服(1)信息不全面,(2)是否可以放宽其假设,以及(3)实施问题。
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引用次数: 0
Will the Institute for Clinical and Economic Review’s Shared Savings Approach Decrease Value-Based Prices Most for the Most Severe Diseases? ICER 的 "共享节约 "方法是否会使最严重疾病的价值定价降幅最大?
IF 4.9 2区 医学 Q1 ECONOMICS Pub Date : 2025-01-01 DOI: 10.1016/j.jval.2024.09.002
Jason Shafrin PhD , Shanshan Wang MS , Khounish Sharma BS , Kathryn Spurrier BA , Robert J. Nordyke PhD

Objectives

To identify the types of disease most likely to be affected by the Institute for Clinical and Economic Review’s (ICER) shared savings assumptions.

Methods

For diseases with treatments that were Food and Drug Administration approved between 2019 and 2023, annual direct and indirect economic burden and characteristics of each disease were extracted from peer-reviewed literature. ICER’s shared savings methodology was applied 2 ways: 50/50 shared savings and $150 000 cost-offset cap. The primary outcome was the difference in eligible cost savings provided by a hypothetical disease cure under ICER’s 2 shared savings methods. Characteristics of diseases most impacted by these 2 methods were evaluated descriptively.

Results

Food and Drug Administration approved 260 therapies for 89 unique diseases between 2019 and 2023. Shared savings reduced value of a hypothetical cure for hemophilia A most (50/50 method: −$367 670 per year; cap method: −$585 340 per year), followed by acute hepatic porphyria (50/50 method: −$333 948; cap method: −$517 896) and paroxysmal nocturnal hemoglobinuria (50/50 method: −$291 997; cap method: −$433 993). Compared with diseases with annual burdens <$150 000, those ≥$150 000 had earlier disease onset by 22.0 years (age 12.3 vs 34.3), lower life expectancy by 10.6 years (55.8 vs 66.4 years), and lower disease prevalence (4.7 vs 1981.5 per 100 000). Shared savings’ impact on health-benefit price benchmarks was projected to be larger for diseases with shorter life expectancy (ρ = −0.319; p =.005), worse quality of life (ρ = -0.263; P =.020), and lower prevalence (ρ = −0.418; P < .001).

Conclusions

ICER’s shared savings assumptions would most likely have the largest negative impact on health-benefit price benchmarks for rare, severe, and pediatric diseases.
目标确定最有可能受到临床与经济研究所(ICER)共同节约假设影响的疾病类型:对于 2019 年至 2023 年期间 FDA 批准治疗的疾病,从同行评审文献中提取了每种疾病的年度直接和间接经济负担及特征。ICER 的共享节约方法有两种应用方式:50/50共享节约和150,000美元成本抵消上限。主要结果是在 ICER 的两种共同节约方法下,假设疾病治愈所节省的符合条件的成本差异。对这两种方法影响最大的疾病的特征进行了描述性评估:FDA在2019年至2023年期间批准了260种治疗89种疾病的疗法。共享节约使假设治愈血友病 A 的价值降低最多(50/50 法:-367,670 美元/年;上限法:-585,340 美元/年),其次是急性肝性卟啉症(50/50 法:-333,948 美元;上限法:-517,896 美元)和阵发性夜间血红蛋白尿症(50/50 法:-291,997 美元;上限法:-433,993 美元)。与具有年度负担的疾病相比 结论:ICER 的共享节余假设最有可能对罕见病、重症和儿科疾病的医疗福利价格基准产生最大的负面影响。
{"title":"Will the Institute for Clinical and Economic Review’s Shared Savings Approach Decrease Value-Based Prices Most for the Most Severe Diseases?","authors":"Jason Shafrin PhD ,&nbsp;Shanshan Wang MS ,&nbsp;Khounish Sharma BS ,&nbsp;Kathryn Spurrier BA ,&nbsp;Robert J. Nordyke PhD","doi":"10.1016/j.jval.2024.09.002","DOIUrl":"10.1016/j.jval.2024.09.002","url":null,"abstract":"<div><h3>Objectives</h3><div>To identify the types of disease most likely to be affected by the Institute for Clinical and Economic Review’s (ICER) shared savings assumptions.</div></div><div><h3>Methods</h3><div>For diseases with treatments that were Food and Drug Administration approved between 2019 and 2023, annual direct and indirect economic burden and characteristics of each disease were extracted from peer-reviewed literature. ICER’s shared savings methodology was applied 2 ways: 50/50 shared savings and $150 000 cost-offset cap. The primary outcome was the difference in eligible cost savings provided by a hypothetical disease cure under ICER’s 2 shared savings methods. Characteristics of diseases most impacted by these 2 methods were evaluated descriptively.</div></div><div><h3>Results</h3><div>Food and Drug Administration approved 260 therapies for 89 unique diseases between 2019 and 2023. Shared savings reduced value of a hypothetical cure for hemophilia A most (50/50 method: −$367 670 per year; cap method: −$585 340 per year), followed by acute hepatic porphyria (50/50 method: −$333 948; cap method: −$517 896) and paroxysmal nocturnal hemoglobinuria (50/50 method: −$291 997; cap method: −$433 993). Compared with diseases with annual burdens &lt;$150 000, those ≥$150 000 had earlier disease onset by 22.0 years (age 12.3 vs 34.3), lower life expectancy by 10.6 years (55.8 vs 66.4 years), and lower disease prevalence (4.7 vs 1981.5 per 100 000). Shared savings’ impact on health-benefit price benchmarks was projected to be larger for diseases with shorter life expectancy (<em>ρ =</em> −0.319; p =.005), worse quality of life (<em>ρ =</em> -0.263; <em>P</em> =.020), and lower prevalence (<em>ρ =</em> −0.418; <em>P</em> &lt; .001).</div></div><div><h3>Conclusions</h3><div>ICER’s shared savings assumptions would most likely have the largest negative impact on health-benefit price benchmarks for rare, severe, and pediatric diseases.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"28 1","pages":"Pages 25-30"},"PeriodicalIF":4.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Value in Health
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